Catalyst Pharmaceuticals Q3 Earnings Beat, Firdapse Revenues Rise Y/Y

Catalyst Pharmaceuticals CPRX reported adjusted earnings of 68 cents per share for the third quarter of 2025, beating the Zacks Consensus Estimate of 51 cents. The company had recorded adjusted earnings of 57 cents in the year-ago quarter.

Total revenues, the majority of which comprised product revenues, amounted to $148.4 million in the reported quarter, representing growth of 15% year over year. The recorded figure also surpassed the Zacks Consensus Estimate of $136 million.

Catalyst Pharmaceuticals’ top line primarily comprised revenues from the sale of Firdapse, the first approved drug for the treatment of Lambert-Eaton myasthenic syndrome (LEMS), and the epilepsy drug Fycompa (perampanel) CIII. Revenues generated from the sale of the newly launched muscle disease drug, Agamree (vamorolone), also contributed to the top line.

CPRX shares are gaining in the pre-market hours today following the better-than-expected earnings results.

CPRX’s Q3 Results in Detail

Firdapse generated sales worth $92.2 million in the reported quarter, up 16% year over year, driven by organic sales growth. The reported figure beat the Zacks Consensus Estimate of $91.8 million as well as our estimate of $91.9 million. The drug has been witnessing strong demand, increasing prescription rates from LEMS patients and continued diagnosis of new LEMS patients.

In 2023, Catalyst Pharmaceuticals acquired exclusive rights to manufacture and supply Agamree from Santhera Pharmaceuticals through a licensing agreement. In late 2023, the FDA approved Agamree for treating Duchenne Muscular Dystrophy in patients aged two years and older, which gave the company a third approved product. The drug was commercially launched in the United States in the middle of March 2024.

In the reported quarter, Agamree generated revenues worth $32.4 million, which more than doubled year over year. The reported figure beat the Zacks Consensus Estimate of $29.5 million and our estimate of $29.3 million.

Year to date, shares of CPRX have gained 2.4% compared with the industry’s 3% growth.

In 2023, Catalyst Pharmaceuticals acquired the U.S. rights for Fycompa (perampanel) CIII from Eisai Co., Ltd. This acquisition diversified the company’s portfolio by adding a commercial-stage epilepsy asset. Catalyst Pharmaceuticals started recording sales of Fycompa in 2023.

Fycompa generated net product revenues of $23.8 million, down 26% year over year, as tablet generics began hitting the market in late May following the expiration of its first U.S. patent, with another slated to expire in July 2026. Catalyst Pharmaceuticals will also lose exclusivity for the oral suspension version of Fycompa in mid-December 2025. As a result, revenues from this product are expected to further decline in future periods as additional generic competition enters the market. The reported figure, however, beat the Zacks Consensus Estimate of $15.2 million as well as our model estimate of $14.5 million.

Research and development expenses were $2.7 million in the reported quarter, down 19% year over year. Selling, general and administrative expenses totaled $47.5 million, up 3% year over year.

As of Sept. 30, 2025, Catalyst Pharmaceuticals had cash, cash equivalents and investments worth $689.9 million compared with $652.8 million as of June 30, 2025.

CPRX Raises 2025 Sales Guidance

Following the better-than-expected third-quarter earnings results, Catalyst Pharmaceuticals has raised its full-year sales guidance. In 2025, CPRX now expects total revenues between $565 million and $585 million, up from the previous guided range of $545-$565 million, reflecting continued growth in product revenues. This is also likely contributing to the stock price gain.

Firdapse revenues are expected to remain between $355 million and $360 million. Agamree revenues are now expected to be in the band of $105-$115 million, up from the previous anticipated range of $100-$110 million in 2025. Catalyst Pharmaceuticals has also raised its guidance for Fycompa revenues to $100-$110 million, up from the previously guided range of $90-$95 million, as the drug delivered stronger than originally forecasted sales amid generic competition.

CPRX Key Updates

Catalyst Pharmaceuticals continues to evaluate Agamree in the SUMMIT study, a five-year follow-up study designed to evaluate the drug’s long-term clinical safety profile, including potential benefits on behavior, stature, bone health, and cardiovascular health. The study is currently enrolling patients.

During the third quarter, Catalyst Pharmaceuticals secured a significant win by settling its Firdapse patent litigation with Lupin, effectively blocking generic competition in the United States until February 2035. Under the agreement, Lupin will not launch a generic version of Firdapse before Feb. 25, 2035, and all ongoing litigation between the parties has been dismissed.

The deal strengthens CPRX’s long-term revenue outlook, as Firdapse remains its core commercial asset, representing 62% of 2024 product sales and generating $260.8 million in the first nine months of 2025 alone. While the company has already settled similar disputes with Teva and Inventia, litigation with one remaining defendant, Hetero, is still ongoing. A tentative trial date has been set for March 2026. Even so, the Lupin settlement is a major step in preserving Firdapse’s market exclusivity and shielding CPRX from near-term generic erosion.

Catalyst Pharmaceuticals, Inc. Price, Consensus and EPS Surprise

Catalyst Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Catalyst Pharmaceuticals, Inc. Quote

CPRX’s Zacks Rank & Stocks to Consider

Catalyst Pharmaceuticals currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals ANIP, Acadia Pharmaceuticals ACAD and Amicus Therapeutics FOLD. While FOLD currently sports a Zacks Rank #1 (Strong Buy), ANIP and ACAD carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Amicus Therapeutics’ earnings per share have remained constant at 31 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from 69 cents to 70 cents. Year to date, shares of FOLD have lost 4.5%.

Amicus Therapeutics’ earnings beat estimates in one of the trailing four quarters, missing the mark thrice, with the average negative surprise being 20.21%.

In the past 60 days, estimates for ANI Pharmaceuticals’ earnings per share have increased from $7.25 to $7.29 for 2025. During the same time, earnings per share estimates for 2026 have increased from $7.74 to $7.81. Year to date, shares of ANIP have surged 67.6%.

ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, the average surprise being 22.66%.

In the past 60 days, estimates for Acadia Pharmaceuticals’ earnings per share have increased from 52 cents to 53 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from 78 cents to 84 cents. Year to date, shares of ACAD have surged 21.7%.

Acadia Pharmaceuticals’ earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 16.90%.

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This article originally published on Zacks Investment Research (zacks.com).

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